FDA product code · Radiology · Class 2
LLZ: System, Image Processing, Radiological
LLZ is FDA's product code for "System, Image Processing, Radiological": a Class 2 device classified under 21 CFR 892.2050, reviewed by the Radiology panel.
510(k) review time for LLZ
Across 656 510(k) clearances under LLZ decided from 2018-01-01 to 2026-10-06, the median was 129 days from FDA receipt to decision. Half took between 60 and 212 days, and 80% were decided within 237 days. These are past clearances, not a forecast for a new submission.
| Fastest | 7 |
|---|---|
| 25th percentile | 60 |
| Median | 129 |
| 75th percentile | 212 |
| 80th percentile | 237 |
| 90th percentile | 271 |
| Slowest | 728 |
| Year | Median days | n |
|---|---|---|
| 2018 | 105 | 104 |
| 2019 | 107 | 74 |
| 2020 | 115 | 81 |
| 2021 | 116 | 83 |
| 2022 | 137 | 65 |
| 2023 | 157 | 87 |
| 2024 | 131 | 62 |
| 2025 | 173 | 58 |
| 2026 (to 10-06, partial) | 110 | 42 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
LLZ in the public FDA record
| 510(k) clearances, all years | 2,287 |
|---|---|
| Device recalls | 554 |
| Establishment listings | 2,001 |
| GUDID device identifiers | 5,423 |
Counts of records, not of devices or events. Adverse event reports for LLZ are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite LLZ
7 FDA recognized consensus standards cite LLZ, among them NEMA XR 22-2006 (R2020); NEMA XR 23-2006 (R2020); ISO IEC 10918-1 First edition 1994-02-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-165 NEMA XR 22-2006 (R2020) — Quality Control Manual Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
- 12-166 NEMA XR 23-2006 (R2020) — Quality Control Manual Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
- 12-261 ISO IEC 10918-1 First edition 1994-02-15 — Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
- 12-344 IEC 62563-2 Edition 1.0 2021-11 — Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy tests for medical image displays
- 12-360 IEC 63145-10 Edition 1.0 2023-09 — Eyewear display - Part 10: Specifications
- 12-363 NEMA PS 3.1 - 3.20 2024e — Digital Imaging and Communications in Medicine (DICOM) Set
- 12-385 NEMA PS 3.1 - 3.20 2025d — Digital Imaging and Communications in Medicine (DICOM) Set
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.